Browse Device Recalls
2,260 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,260 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 2,260 FDA device recalls in 2021.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material N... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Nu... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35 | Sterility may be compromised due to an unsealed pouch | Class II | Medtronic Vascular |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 85mm Material Nu... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is inten... | Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Sh... | Class II | Biomet, Inc. |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 24m Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 14mm Material Nu... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Nu... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 42mm Material Nu... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 28mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Nu... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | SARS-CoV-2 Antigen Test | QIAGEN has become aware of the potential for false positive results to occur with some patient sa... | Class II | Qiagen Sciences LLC |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Nu... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40 | Sterility may be compromised due to an unsealed pouch | Class II | Medtronic Vascular |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Nu... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 20mm Material Nu... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 80mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 95mm Material Nu... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 100mm Material N... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W... | There is a risk that the device can start a fire if flammable liquids contact and enter the device. | Class II | Hamilton Co |
| Jan 15, 2021 | ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Produc... | An internal tubing component in the flow path was made with incorrect material which was not test... | Class II | Northgate Technologies, Inc. |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375 | Sterility may be compromised due to an unsealed pouch | Class II | Medtronic Vascular |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 75mm Material Nu... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 90mm Material Nu... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 71... | An internal tubing component in the flow path was made with incorrect material which was not test... | Class II | Northgate Technologies, Inc. |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 88mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 22mm Material Nu... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30 | Sterility may be compromised due to an unsealed pouch | Class II | Medtronic Vascular |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Nu... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 38mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Nu... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.